2018 Report on Scientific Conference with Expenses Over $30,000

21st Century Cures Act Reports on Scientific Conferences

Section 3074 of 21st Century Cures Act requires the FDA to report on scientific conferences hosted, sponsored, co-sponsored, or attendance at non-Federal Scientific Meetings with FDA expenses in excess of $30,000. The following outlines the total expenses for each scientific meeting together with other pertinent information including how the conference advanced the mission of the agency, a description of the conference activities. Section 3074 requires additional information of compelling circumstances for the costs exceeding $150,000.

FDA Small Business Regulatory Education for Industry (REdI) Conference May 2018

Conference Information
Applicable Conference Type: FDA-Hosted
Conference Location: San Francisco, CA
Conference Start Date: 5/15/18
Conference End Date: 5/16/18

Cost and Attendee Information
Total FDA cost of the conference: $146,702
Total number of individuals whose travel expenses were paid by the FDA: 45

General description of the scientific conference activities:
The Regulatory Education for Industry (REdI) Conference is an FDA-led forum that brings together regulatory educators from FDA. Because the regulatory principles of drugs and devices are both similar and different, the REdI Conference featured a cross-cutting plenary addressing issues which impact both drugs and devices, as well as individual break-out sessions which focused on the unique issues and regulatory requirements of drugs and devices.

2018 American Society of Clinical Oncology Annual Meeting

Conference Information
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Chicago, Illinois
Conference Start Date: 6/1/18
Conference End Date: 6/5/18

Cost and Attendee Information
Total FDA cost of the conference: $86,962
Total number of individuals whose travel expenses were paid by the FDA: 58

Conference Justification Information
Explanation of how conference advanced the mission of FDA:
Attending this meeting allowed reviewers in FDA, to gain in-depth and up-to-date information on basic, translational, and clinical cancer research including biomarker diagnostic development and interpretation. Additionally, information about diagnostics research and implementation in the clinical setting in the area of immunohistochemistry, next-generation sequencing and other important technologies which is critical to FDA's mission for regulatory review and approval of in vitro diagnostic devices.

General description of the scientific conference activities:
The conference covered many pertinent areas, including method development, next generation diagnostics in cancer, and new biomarker research and development.

2018 Institute of Food Technologists (IFT) Annual Meeting & Food Expo

Conference Information
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Chicago, Illinois
Conference Start Date: 7/15/18
Conference End Date: 7/17/18

Cost and Attendee Information
Total FDA cost of the conference: $85,934
Total number of individuals whose travel expenses were paid by the FDA: 16

Conference Justification Information
Explanation of how conference advanced the mission of FDA:
Attending this conference advances the mission of FDA by allowing FDA Staff to develop expertise in nutrition and labeling and a venue for FDA employees to build contacts for greater communication and potential collaboration. It is necessary for FDA Staff to remain current with respect to the research being done that would enhance its ability to support Agency activities.

General description of the scientific conference activities:
The Institute of Food Technologists (IFT) Annual Meeting & Food Expo is where the most creative minds in the science of food—including industry, government, and academia—come together with purpose and vision to share the latest research, innovative solutions and forward-thinking topics in food science and technology

2018 Controlled Release Society Annual Meeting and Exposition

Conference Information
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: New York, New York
Conference Start Date: 7/22/18
Conference End Date: 7/24/18

Cost and Attendee Information
Total FDA cost of the conference: $65,662
Total number of individuals whose travel expenses were paid by the FDA: 31

Conference Justification Information
Explanation of how conference advanced the mission of FDA:
Attending this conference provided FDA staff not only an outstanding scientific program, but also a unique opportunity to meet peers face-to-face and discuss how to maintain and enhance the significance of society in years to come. Through collective efforts, FDA can contribute to raising the existing science and technology to a new level.

General description of the scientific conference activities:
The Controlled Release Society Annual Meeting and Exposition(CRS) is one of the most respected and unique societies that covers new technologies and science in the multi-disciplinary delivery fields. CRS has succeeded in fostering significant progress in the areas of bioengineering, drug delivery, material science, pharmaceutics, consumer and diversified products, and veterinary science.

Heart Rhythm Society Scientific Sessions 2018

Conference Information
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Boston, Massachusetts
Conference Start Date: 5/9/18
Conference End Date: 5/12/18

Cost and Attendee Information
Total FDA cost of the conference: $64,200
Total number of individuals whose travel expenses were paid by the FDA: 32

Conference Justification Information
Explanation of how conference advanced the mission of FDA:
FDA attended to further surveillance activities to monitor for truthful, non-misleading, and accurate advertising and promotion for prescription drug products. This advanced the mission of FDA guarding against false and misleading advertising and promotion through comprehensive surveillance.

General description of the scientific conference activities:
The Heart Rhythm Society’s 39th Annual Scientific Sessions convened the finest clinicians, scientists, researchers, and innovators in the field of cardiac pacing and electrophysiology.

FDA Small Business Regulatory Education for Industry (REdI) Conference September 2018

Conference Information
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Washington, D.C.
Conference Start Date: 9/12/18
Conference End Date: 9/13/18

Cost and Attendee Information
Total FDA cost of the conference: $60,543
Total number of individuals whose travel expenses were paid by the FDA: 100

Conference Justification Information
Explanation of how conference advanced the mission of FDA:
FDA Small Business Regulatory Education for Industry (REdI) Conference September 2018 was an opportunity for FDA to present FDA's research on complex generic product development. This presentation helps industry develop complex generic products in accordance with FDA guidance's. This advances FDA mission by providing real-time, contemporary, and interactive education of medical devices.

General description of the scientific conference activities:
FDA staff presentation included current, significant premarket and post market topics that addressed the laws, regulations, guidance, and policies that govern the overall regulation of medical devices.

2018 21st Annual American Society of Gene and Cell Therapy Meeting

Conference Information
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Chicago, Illinois
Conference Start Date: 5/16/18
Conference End Date: 5/19/18

Cost and Attendee Information
Total FDA cost of the conference: $59,976
Total number of individuals whose travel expenses were paid by the FDA: 35

Conference Justification Information
Explanation of how conference advanced the mission of FDA:
Attending the 2018 21st Annual American Society of Gene and Cell Therapy advances the mission of FDA by allowing FDA Staff to be updated on the most recent knowledge, science and technology related with gene therapy products in order to improve FDA's oversight duties.

General description of the scientific conference activities:
The 2018 21st Annual American Society of Gene and Cell Therapy Meeting featured ground breaking clinical trial results, cutting edge technology advancements, social networking events, and much more.

2018 Annual Meeting of Association of American Feed Control Officials AAFCO

Conference Information
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Fort Lauderdale, Florida
Conference Start Date: 7/28/18
Conference End Date: 8/1/18

Cost and Attendee Information
Total FDA cost of the conference: $54,475
Total number of individuals whose travel expenses were paid by the FDA: 34

Conference Justification Information
Explanation of how conference advanced the mission of FDA:
Attendance is mission critical in providing regulatory expertise to Association of American Feed Control Officials (AAFCO) and state feed control officials, who are FDA partners and will implement federal regulation and policy to ensure the health of animals and humans.

General description of the scientific conference activities:
The Annual Meeting of Association of American Feed Control Officials AAFCO serves as an important forum for the federal and state members to work together to develop and implement uniform and equitable model laws, regulations, standards, definitions, and enforcement policies for regulating the manufacture, distribution, and sale of animal feeds.

12th Workshop on Recent Issues in Bioanalysis

Conference Information
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Philadelphia, Pennsylvania
Conference Start Date: 4/9/18
Conference End Date: 4/13/18

Cost and Attendee Information
Total FDA cost of the conference: $50,015
Total number of individuals whose travel expenses were paid by the FDA: 20

Conference Justification Information
Explanation of how conference advanced the mission of FDA:
The 12th Workshop on Recent Issues in Bioanalysis advanced the mission of FDA because it gave attendees the opportunity to learn about the use of mass spectrometry in protein therapeutic and about advances in the field.

General description of the scientific conference activities:
The 12th Workshop on Recent Issues in Bioanalysis was attended by over 900 professionals representing pharmas/biopharmas, biotechs, CROs and multiple regulatory agencies working on both small and large molecules bioanalysis

256th ACS National Meeting and Exposition American Chemical Society (ACS)

Conference Information
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Boston, Massachusetts
Conference Start Date: 8/19/18
Conference End Date: 8/23/18

Cost and Attendee Information
Total FDA cost of the conference: $48,438
Total number of individuals whose travel expenses were paid by the FDA: 18

Conference Justification Information
Explanation of how conference advanced the mission of FDA:
This conference advances the mission of FDA by ensuring FDA staff stays well versed in these areas in order to promote and protect the public's health. Part of FDA's mission is to promote and protect the public's health by ensuring a safe food supply in the United States. This industry, however, has become increasingly complex, with advances made in technologies used in food production and packaging.

General description of the scientific conference activities:
The American Chemical Society (ACS) organizes two national meetings & expositions each year, and each one attracts chemists, chemical engineers, academicians, graduate and undergraduate students, and other related professionals.

International Standards Organization Technical Committee 194

Conference Information
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Seoul, South Korea
Conference Start Date: 10/13/17
Conference End Date: 10/21/17

Cost and Attendee Information
Total FDA cost of the conference: $45,099
Total number of individuals whose travel expenses were paid by the FDA: 9

Conference Justification Information
Explanation of how conference advanced the mission of FDA:
Attending this conference advanced the mission of the FDA because it offered the FDA knowledge on the standardization of the approach to biological and clinical evaluation of medical and dental materials and devices together with standardization of biological test methods applicable to those materials and devices as well as good clinical practice principles to clinical investigations in humans of those devices.

General description of the scientific conference activities:
This standards meeting is critical in the pre-market review process of medical devices for the FDA.

Transcather Cardiovascular Therapeutics (TCT 2017)

Conference Information
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Denver, Colorado
Conference Start Date: 10/29/17
Conference End Date: 11/2/17

Cost and Attendee Information
Total FDA cost of the conference: $44,265
Total number of individuals whose travel expenses were paid by the FDA: 25

Conference Justification Information
Explanation of how conference advanced the mission of FDA:
Attending this conference advances the mission of FDA by providing FDA Staff with the opportunity to learn about the latest advances in cardiovascular diseases and treatments through the various scientific sessions offered, obtain hands-on experience with the most cutting-edge technology in the field via the exhibit hall, and interact with a number of key stakeholders through various talks and panel discussions.

General description of the scientific conference activities:
Transcather Cardiovascular Therapeutics Conference(TCT) is the world’s largest educational meeting specializing in interventional cardiovascular medicine. TCT Conference has been showcasing the latest advances in current therapies and clinical research.

11th Global Microbial Identifier (GMI) meeting

Conference Information
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Geneva, Switzerland
Conference Start Date: 5/16/18
Conference End Date: 5/18/18

Cost and Attendee Information
Total FDA cost of the conference: $42,766
Total number of individuals whose travel expenses were paid by the FDA: 9

Conference Justification Information
Explanation of how conference advanced the mission of FDA:
Attending this conference gave FDA staff a great opportunity to present and learn current developments on using WGS for food safety management and resistance surveillance using One Health approach, which are critical to NARMS surveillance and research conducted at FDA. Without up-to-date and cutting-edge knowledge of the field, the antimicrobial resistance surveillance and research will not be using the best approach or methodologies available to best support FDA regulatory mission.

General description of the scientific conference activities:
The Global Microbial Identifier (GMI) conference focuses on the impact of whole genome sequencing (WGS) on food safety management, including benefits and risks, data gaps, global data sharing of sequence and meta data, One Health surveillance, and metagenomic analysis of microbial communities.

2017 American Association of Blood Banks (AABB) Annual Meeting

Conference Information
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: San Diego, California
Conference Start Date: 10/7/17
Conference End Date: 10/10/17

Cost and Attendee Information
Total FDA cost of the conference: $38,607
Total number of individuals whose travel expenses were paid by the FDA: 21

Conference Justification Information
Explanation of how conference advanced the mission of FDA:
This conference advances the mission of FDA by exposing FDA staff to new/updated information, as well as scientific leaders in the field, and gain critical knowledge to carry out assigned duties and thereby support the core mission of Center for Biologics Evaluation and Research (CDER).

General description of the scientific conference activities:
The American Association of Blood Banks (AABB) Annual Meeting serves as the preeminent national meeting for transfusion medicine issues, especially emerging threats to the blood supply and novel strategies for donor testing and diagnosis.

Transcather Cardiovascular Therapeutics (TCT) 2018

Conference Information
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: San Diego, California
Conference Start Date: 9/21/18
Conference End Date: 9/25/18

Cost and Attendee Information
Total FDA cost of the conference: $38,547
Total number of individuals whose travel expenses were paid by the FDA: 28

General description of the scientific conference activities:
Transcather Cardiovascular Therapeutics Conference(TCT) is the world’s largest educational meeting specializing in interventional cardiovascular medicine. The conference included various talks and panel discussions.

APhA 2018 Annual Meeting and Expo

Conference Information
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Nashville, Tennessee
Conference Start Date: 3/16/18
Conference End Date: 3/19/18

Cost and Attendee Information
Total FDA cost of the conference: $37,063
Total number of individuals whose travel expenses were paid by the FDA: 15

Conference Justification Information
Explanation of how conference advanced the mission of FDA:
This conference advances the mission of FDA by allowing FDA staff to continue to be knowledgeable in all areas of medicine and aware of various challenges in healthcare in order to protect the public health and safety.

General description of the scientific conference activities:
The American Pharmacists Association Annual Meeting provides a great opportunity for FDA pharmacists and regulators to discuss topics that affect public health and the profession of pharmacy with other pharmaceuticals, biotechnology, government, students, and patient groups.

72nd Tobacco Science Research Conference "Building Science and Evidence

Conference Information
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Memphis, Tennessee
Conference Start Date: 9/16/18
Conference End Date: 9/19/18

Cost and Attendee Information
Total FDA cost of the conference: $36,631
Total number of individuals whose travel expenses were paid by the FDA: 16
Conference Justification Information
Explanation of how conference advanced the mission of FDA:
This conference advanced the mission of FDA by allowing FDA to be exposed to cutting-edge research in basic tobacco science and public health standards for tobacco regulation; which is instrumental to FDA.

General description of the scientific conference activities:
The Tobacco Science Research Conference (TSRC) is one of the leading conferences dedicated to all aspects of tobacco research, with an emphasis on basic science and analytical methods.

2018 North American Chemical Residue Workshop

Conference Information
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Naples, Florida
Conference Start Date: 7/22/18
Conference End Date: 7/25/18

Cost and Attendee Information
Total FDA cost of the conference: $33,762
Total number of individuals whose travel expenses were paid by the FDA: 18
Conference Justification Information
Explanation of how conference advanced the mission of FDA:
The shared knowledge and discussions during the poster and oral sessions enabled FDA Staff to improve current methods and better use technology in support of FDA mission.

General description of the scientific conference activities:
2018 North American Chemical Residue Workshop gave FDA staff the opportunity to be updated on new technology and method developments to detect veterinary drug residues.

Cutting Edge of Transplantation

Conference Information
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Phoenix, Arizona
Conference Start Date: 2/8/18
Conference End Date: 2/10/18

Cost and Attendee Information
Total FDA cost of the conference: $32,460
Total number of individuals whose travel expenses were paid by the FDA: 15

Conference Justification Information
Explanation of how conference advanced the mission of FDA:
Cutting Edge of Transplantation conference advances the mission of FDA by allowing FDA staff to gain knowledge of current issues involving transplant organ shortage, including defining donor organ criteria, organ demand and availability, and strategies to improve organ quality. Attendance to this conference helps FDA staff with the review of 510(k), premarket submissions.

General description of the scientific conference activities:
The Cutting Edge of Transplantation meeting brings innovative, cutting-edge science and research into an educational setting and bridge the gap from basic to translational to clinical science.

2018 Parenteral Drug Association (PDA)/FDA Joint Regulatory Conference

Conference Information
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Washington, D.C.
Conference Start Date: 9/24/18
Conference End Date: 9/26/18

Cost and Attendee Information
Total FDA cost of the conference: $30,754
Total number of individuals whose travel expenses were paid by the FDA: 13

Conference Justification Information
Explanation of how conference advanced the mission of FDA:
Attendance to the Joint Regulatory Conference furthered the mission of the FDA because the conference provided a forum for discussions on the requirements that assure the availability and delivery of high-quality medical products and offers an opportunity to hear about the latest issues in the regulatory, quality, supply, and compliance areas for medical products in an ever-evolving landscape.

General description of the scientific conference activities:
Attendees heard straight from regulators and industry leaders about how to meet the challenges of developing, manufacturing, and assuring availability and safe supply of necessary medicines to serve the patient.

College on Problems of Drug Dependence 80th Annual Scientific Meeting

Conference Information
Conference Title: College on Problems of Drug Dependence 80th Annual Scientific Meeting
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: San Diego, California
Conference Start Date: 6/9/18
Conference End Date: 6/14/18

Cost and Attendee Information
Total FDA cost of the conference: $30,563
Total number of individuals whose travel expenses were paid by the FDA: 13

Conference Justification Information
Explanation of how conference advanced the mission of FDA:
Given the pivotal role of addiction in tobacco use and the current lack of regulations in addressing tobacco product abuse liability, informing the addiction community of how this research is useful for tobacco regulation would be beneficial for the Center for Tobacco Products (CTP)research activities. Additionally, because the conference focuses on drug dependence, CTP acquired knowledge to inform potential addiction-related tobacco product standards, industry applications, and other areas of tobacco regulation from an addiction and behavioral science perspective, as it is important that CTP is aware of the latest research activities and possibilities within the addiction community.

General description of the scientific conference activities:
The College on Problems of Drug Dependence (CPDD), is the oldest and largest organization in the US dedicated to advancing a scientific approach to substance use and addictive disorders.

Global Summit on Regulatory Science

Conference Information
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Beijing, China
Conference Start Date: 9/25/18
Conference End Date: 9/27/18

Cost and Attendee Information
Total FDA cost of the conference: $36,551
Total number of individuals whose travel expenses were paid by the FDA: 5

Conference Justification Information
Explanation of how conference advanced the mission of FDA:
The conference advanced the mission of FDA because it provided a platform where regulators, policy makers, and bench scientists from various countries could exchange views on how to develop, apply, and implement innovative methodologies into regulatory assessments in their respective countries, as well as harmonizing strategy via global collaboration.

General description of the scientific conference activities:
The Global Summit on Regulatory Science (GSRS) provides an opportunity for scientists from government, industry, and academic-research communities to objectively assess the utility of emerging technologies (such as nanotechnology, imaging, omics for translational science, personalized medicine, medical product safety, and food safety) for addressing regulatory-research questions and to discuss the best way to translate these technologies into real-world applications.

2018 Joint Statistical Meeting by the American Statistical Association ASA

Conference Information
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Vancouver, Canada
Conference Start Date: 7/28/18
Conference End Date: 8/2/18

Cost and Attendee Information
Total FDA cost of the conference: $211,274
Total number of individuals whose travel expenses were paid by the FDA: 60

Conference Justification Information
Explanation of how conference advanced the mission of FDA:
Attendance at the conference advanced the mission of the FDA due to the conversations initiated by questions from the audience. Often, the attendees are contemplating how the design or analysis method presented may be modified for use under slightly different scenarios and the direct insight from the speaker may be crucial for a successful implementation.

General description of the scientific conference activities:
Many of the issues discussed at the Joint Statistical Meetings are the same as those observed in the experiments, research, and clinical trials at the Center for Veterinary Medicine (CVM). The solutions presented and discussed at the conference can often be applied to situations at CVM.

Explanation/description of circumstances for conference exceeding $150,000:
The Joint Statistical Meeting is a highly attended Conference for the Office of Biostatistics in the Office of Translational Sciences. In addition to staff attending as Speakers or Session Chairs, other participants served as recruiters. JSM is considered a major corporate recruitment effort for interviewing candidates for Mathematical Statisticians positions, these positions are identified as hard to fill.

53rd United States Public Health Service Scientific and Training Symposium

Conference Information
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Dallas, Texas
Conference Start Date: 6/4/18
Conference End Date: 6/7/18

Cost and Attendee Information
Total FDA cost of the conference: $182,014
Total number of individuals whose travel expenses were paid by the FDA: 119

Conference Justification Information
Explanation of how conference advanced the mission of FDA:
Attending the United States Public Health Service Scientific and Training Symposium allowed officers to keep current with state of the art practices, and technology; and to remain proficient in the various FDA programs to which they are assigned.

General description of the scientific conference activities:
Each year the 6,700 Commissioned Officers complete their continuing education requirements in a variety of venues. The U.S. Public Health Service Education and Training Symposium is an excellent means of obtaining continuing education credits across a variety of disciplines.

Explanation/description of circumstances for conference exceeding $150,000:
As an HHS OPDIV, FDA hold one of the largest amounts of Commissioned Corps Officers with approximately 1,200. FDA sent eighteen percent of their Commissioned Corps Officers to the 53rd United States Public Health Service (USPHS) Scientific and Training Symposium. The USPHS Scientific and Training Symposium is the only conference that is dedicated to the Commissioned Corps where officers can receive continuing education credits, network with other officers across different agencies, and learn more about the new initiatives and requirements for their specific category. It is imperative FDA officers stay up to date on Commissioned Corps information and attending this conference allows them to do such which becomes beneficial to not only the officer but also the agency.

2018 International Association for Food Protection Annual Meeting

Conference Information
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Salt Lake, Utah
Conference Start Date: 7/6/18
Conference End Date: 7/12/18

Cost and Attendee Information
Total FDA cost of the conference: $176,420
Total number of individuals whose travel expenses were paid by the FDA: 72

Conference Justification Information
Explanation of how conference advanced the mission of FDA:
Attending the International Association for Food Protection Annual Meeting advanced the mission of FDA by allowing FDA staff to network with peer professionals, strengthen and build relationships, along with providing awareness of the latest advances in analytical technology and methodology.

General description of the scientific conference activities:
The International Association for Food Protection focuses on issues relative to current and emerging food safety issues, science, and innovative solutions to new and recurring problems in food safety and defense.

Explanation/description of circumstances for conference exceeding $150,000:
The International Association for Food Protection Annual Meeting is a widely-attended conference that provides food safety professionals worldwide with a forum to exchange information on protecting the food supply in all fields of food safety. Because of the importance of the meeting, seventy-two FDA professionals attended causing the cost to exceed $150,000.

Society of Toxicology (SOT) 57th Annual Meeting and ToxExpo

Conference Information
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: San Antonio, Texas
Conference Start Date: 3/11/18
Conference End Date: 3/15/18

Cost and Attendee Information
Total FDA cost of the conference: $172,440
Total number of individuals whose travel expenses were paid by the FDA: 94

Conference Justification Information
Explanation of how conference advanced the mission of FDA:
By attending this conference, attendees stayed abreast of current developments in toxicology, and also gain state knowledge to better perform their present toxicology consulting duties as an expert toxicologist in CDRH. Toxicology plays an important role in the pre-market approval process of medical devices. The knowledge gained from the meeting, and discussions with other scientist will facilitate review of submissions and provide more in-depth knowledge regarding new materials in medical devices having varied toxicology profiles.

General description of the scientific conference activities:
The Society of Toxicology (SOT) is a professional and scholarly organization of scientists from academic institutions, government, and industry representing the great variety of scientists who practice toxicology in the US and abroad.

Explanation/description of circumstances for conference exceeding $150,000:
The Society of Toxicology (SOT) is a professional and scholarly organization of scientists from academic institutions, government, and industry who practice toxicology in the US and abroad. The Society’s mission is to create a safer and healthier world by advancing the science and increasing the impact of toxicology which aligns with FDA's mission to promote and protect the public health. Advances in science that impact toxicologic assessment are presented and discussed at SOT. This annual training is essential to FDA employees as it provides an update in experimental regulatory toxicology which is the critical element for recertification as a reviewer. There is no in-house or metro area training available in these critical disciplines to match our expertise to our sponsor's level. As stated before, SOT meetings are the sole provider for this training.

American Society of Clinical Pharmacology and Therapeutics (ASCPT) Annual Meeting 2018

Conference Information
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Orlando, Florida
Conference Start Date: 3/21/18
Conference End Date: 3/24/18

Cost and Attendee Information
Total FDA cost of the conference: $145,263
Total number of individuals whose travel expenses were paid by the FDA: 53

Conference Justification Information
Explanation of how conference advanced the mission of FDA:
The American Society for Clinical Pharmacology and Therapeutics (ASCPT) is the largest scientific and professional organization serving the disciplines of Clinical Pharmacology and Translational Medicine. Specifically, this forum focuses on the biomarkers that is related to the ongoing FDA research projects, on system pharmacology and smoking related pharmacogenomics (related to health, and physiologic effects of tobacco use.

General description of the scientific conference activities:
The American Society for Clinical Pharmacology and Therapeutics (ASCPT) was founded in 1900 and consists of over 2,300 professionals whose primary interest is to advance the science and practice of clinical pharmacology and translational medicine for the therapeutic benefit of patients and society.

34th International Conference on Pharmacoepidemiology and Therapeutic Risk Management

Conference Information
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Prague, Czech Republic
Conference Start Date: 8/22/18
Conference End Date: 8/26/18

Cost and Attendee Information
Total FDA cost of the conference: $118,927
Total number of individuals whose travel expenses were paid by the FDA: 25

Conference Justification Information
Explanation of how conference advanced the mission of FDA:
This enhances the FDA mission and knowledge by allowing the individual to develop new evidence that may substantially add to the benefit/risk assessment throughout the lifecycle of medicines.

General description of the scientific conference activities:
This conference is critical for FDA scientists to be updated on the latest science in drug safety, so it can be applied in regulatory decision making to ensure the safety of the drugs used by the American people.

2018 American Association for Cancer Research Annual Meeting

Conference Information
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Chicago, Illinois
Conference Start Date: 4/15/18
Conference End Date: 4/18/18

Cost and Attendee Information
Total FDA cost of the conference: $112,166
Total number of individuals whose travel expenses were paid by the FDA: 42

Conference Justification Information
Explanation of how conference advanced the mission of FDA:
Attendance the mission of the American Association for Cancer Research 2018 conference is mission critical for FDA to learn about current advances in cancer biology and technology that foreshadow the regulatory needs of the Agency as personalized medicine approaches to medical product development are increasingly adopted. In particular, the field of oncology is changing extremely rapidly, and the Agency must stay up‐to‐date with current trends and the scope of novel products in the pipeline. Many of the sessions are educational which will provide important information about the state of cancer medicine.

General description of the scientific conference activities:
The mission of the American Association for Cancer Research (AACR) is to prevent and cure cancer through research, education, communication, and collaboration. AACR is the world's oldest and largest professional association related to cancer research.

Society for Research on Nicotine and Tobacco 24th Annual Meeting

Conference Information
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Baltimore, Maryland
Conference Start Date: 2/21/18
Conference End Date: 2/24/18

Cost and Attendee Information
Total FDA cost of the conference: $106,003
Total number of individuals whose travel expenses were paid by the FDA: 105

Conference Justification Information
Explanation of how conference advanced the mission of FDA:
Attending the Society for Research on Nicotine and Tobacco Annual Meeting provided an opportunity for FDA scientists and staff to meet with FDA-funded researchers and stakeholders concerning their research, to discuss research progress and future plans, as well as hear the latest research which will help to identify research gaps. The conference gave FDA staff the opportunity to communicate and exhibit FDA latest cutting-edge research, compliance and enforcement practices and education campaigns.

General description of the scientific conference activities:
Society for Research on Nicotine and Tobacco Annual Meeting is the leading association dedicated to all aspects of research on nicotine and tobacco. The 2018 Society for Research on Nicotine and Tobacco 24th Annual Meeting will bring together diverse tobacco and nicotine researchers and tobacco control practitioners to discuss their work and share ideas.

2018 American Society of Microbiology National Meeting

Conference Information
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Atlanta, Georgia
Conference Start Date: 6/7/18
Conference End Date: 6/11/18

Cost and Attendee Information
Total FDA cost of the conference: $85,952
Total number of individuals whose travel expenses were paid by the FDA: 49

Conference Justification Information
Explanation of how conference advanced the mission of FDA:
Attending this conference is critical to producing relevant content in pre-submissions and making accurate risk assessments for de novo and PMA product applications. Additionally, learning about laboratories' experiences with new technology allowed attendees to better anticipate potential concerns with emerging technologies and write more robust risk/benefit documents. This meeting provides access to real-world data that ultimately helps to uphold FDA's mission of promoting and protecting public health.

General description of the scientific conference activities:
The American Society for Microbiology (ASM), is a professional organization for scientists who study viruses, bacteria, fungi, algae, and protozoa as well as other aspects of microbiology. FDA has a responsibility to provide recommendations to sponsors based upon the current state-of-the-art for clinical practice and microbiology. ASM Microbe presents the latest in microbiology technology and clinical practice guidelines.

2018 International Conference on Harmonization

Conference Information
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Kobe, Japan
Conference Start Date: 6/2/18
Conference End Date: 6/7/18

Cost and Attendee Information
Total FDA cost of the conference: $78,552
Total number of individuals whose travel expenses were paid by the FDA: 36

Conference Justification Information
Explanation of how conference advanced the mission of FDA:
FDA's attendance is essential for the work groups to progress in harmonization of various guidance documents. The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) responds to the increasingly global face of drug development. ICH's mission is to achieve greater harmonization worldwide to ensure that safe, effective, and high-quality medicines are developed and registered in the most resource-efficient manner.

General description of the scientific conference activities:
The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration.

122nd Association of Food and Drug Officials Annual Educational Conference

Conference Information
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Burlington, Vermont
Conference Start Date: 6/9/18
Conference End Date: 6/13/18

Cost and Attendee Information
Total FDA cost of the conference: $72,589
Total number of individuals whose travel expenses were paid by the FDA: 40

Conference Justification Information
Explanation of how conference advanced the mission of FDA:
The FDA is a member of the Association of Food and Drug Officials and serves in an advisory role on several committees tasked with educating members consisting of food and drug regulatory officials and industry. FDA attendance fosters collaboration and leveraging of effective public health programs and supports and enhances compliance within regulated industry.

General description of the scientific conference activities:
This educational conference is an opportunity that allows individuals from government, industry, and the public to participate, listen, and learn valuable information and develop initiatives concerning food, drug, medical device, cosmetic, and product safety issues.

7th Manufactured Food Regulatory Program Alliance (MFRPA) Meeting

Conference Information
Applicable Conference Type: FDA Hosted/Sponsored/Co-Sponsored
Conference Location: Albuquerque, New Mexico
Conference Start Date: 1/29/18
Conference End Date: 2/1/18

Cost and Attendee Information
Total FDA cost of the conference: $69,391
Total number of individuals whose travel expenses were paid by the FDA: 56

Conference Justification Information
Explanation of how conference advanced the mission of FDA:
Attendance at the Manufactured Food Regulatory Program Alliance (MFRPA) Meeting is a requirement of the state program's cooperative agreement. The FDA cooperative agreement has clear goals and expectations/requirements for activities related to national collaboration and best practices and our annual meeting is important in fulfilling this goal. Contributing content to the meeting and attending the meeting is are requirement under the cooperative agreement.

General description of the scientific conference activities:
The Manufactured Food Regulatory Program Alliance (MFRPA) Meeting must be held annually to ensure state programs funded through the cooperative agreement receive the training, resources, and support from FDA to achieve full conformance with the Manufactured Food Regulatory Program Standards within 5 years and sustain conformant.

ID Week 2017

Conference Information
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: San Diego, California
Conference Start Date: 10/4/17
Conference End Date: 10/8/17

Cost and Attendee Information
Total FDA cost of the conference: $65,354
Total number of individuals whose travel expenses were paid by the FDA: 24

Conference Justification Information
Explanation of how conference advanced the mission of FDA:
The meeting provided state-of-the-art updates to FDA staff on key topics and issues. The material presented at this meeting allowed FDA staff to efficiently and accurately contribute to FDA reviews by providing state-of-the art recommendations. This material is essential to accomplish the mission of FDA Division of Microbiology Devices.

General description of the scientific conference activities:
IDWeek is the annual scientific meeting where infectious diseases professionals can meet, share experiences, and develop collaborations. With the theme—Advancing Science, Improving Care—IDWeek features the latest science and bench-to-bedside approaches in prevention, diagnosis, treatment, and epidemiology of infectious diseases, including HIV, across the lifespan.

2018 Conference for Food Protection

Conference Information
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Richmond, Virginia
Conference Start Date: 4/13/18
Conference End Date: 4/20/18

Cost and Attendee Information
Total FDA cost of the conference: $63,650
Total number of individuals whose travel expenses were paid by the FDA: 25

Conference Justification Information
Explanation of how conference advanced the mission of FDA:
Active participation at the biennially-held Conference for Food Protection (CFP) by FDA personnel is vital to the success of the Conference and the FDA's mission to ensure the safety of the food supply.

General description of the scientific conference activities:
The biennially-held Conference for Food Protection (CFP or Conference) brings together representatives from the food industry, federal, state, and local government, academia, and consumer organizations to identify and address emerging problems in food safety and formulate recommendations on the requirements in the FDA Food Code and Voluntary National Retail Food Regulatory Program Standards (Retail Program Standards).

2018 Food and Drug Law Institute Annual Conference

Conference Information
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Washington, D.C.
Conference Start Date: 5/23/18
Conference End Date: 5/24/18

Cost and Attendee Information
Total FDA cost of the conference: $63,504
Total number of individuals whose travel expenses were paid by the FDA: 84

Conference Justification Information
Explanation of how conference advanced the mission of FDA:
The Food and Drug Law Institute Annual Conference covered legal, regulatory, policy and economic issues spanning the broad range of FDA’s authority by bringing together experts from the federal government, industry, the private bar, patient and consumer advocates, consulting organizations and academia.

General description of the scientific conference activities:
FDLI’s annual conference is the largest and longest-running legal conference for the entire food and drug law community, including every product category regulated by FDA.

World Conference on Tobacco Or Health (WCTOH)

Conference Information
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Cape Town, South Africa
Conference Start Date: 3/6/18
Conference End Date: 3/9/18

Cost and Attendee Information
Total FDA cost of the conference: $52,779
Total number of individuals whose travel expenses were paid by the FDA: 9

Conference Justification Information
Explanation of how conference advanced the mission of FDA:
It is important for FDA staff to attend this conference, as it presents a unique opportunity to share our research and regulatory efforts, learn of new research findings, and participate in innovated global tobacco health discussions that impacts CTP’s domestic work. The conference offers FDA an opportunity to communicate with other regulators that face similar regulatory challenges, share our findings, learn from presenters, and schedule side meetings with global stakeholders who will also be attending the conference.

General description of the scientific conference activities:
The World Conference on Tobacco or Health (WCTOH) convenes researchers, academics, non-governmental organizations, civil society, scientists, healthcare professionals, regulators, and government officials working on all aspects of tobacco control.

2018 International Liver Congress

Conference Information
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Paris, France
Conference Start Date: 4/11/18
Conference End Date: 4/15/18

Cost and Attendee Information
Total FDA cost of the conference: $47,981
Total number of individuals whose travel expenses were paid by the FDA: 7

Conference Justification Information
Explanation of how conference advanced the mission of FDA:
FDA Staff needs to stay abreast of the latest data regarding investigational drugs for hepatitis C including drugs designated as breakthrough and obtain information related to special populations including transplant, patients with chronic kidney disease, decompensated cirrhotics, and pediatrics, in addition to the latest findings related to assays and resistance development.

General description of the scientific conference activities:
At the ILC, scientific and medical experts from a broad range of fields including hepatology, gastroenterology, internal medicine, cell biology, transplant surgery, infectious diseases, microbiology and virology, pharmacology, pathology and radiology and imaging come together from around the world to learn about the latest in liver research. Specialists share recent data, present studies, and findings, and discuss the hottest topics on liver disease.

National Association of State Departments of Agriculture National Consortium Meeting

Conference Information
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Irvine, California
Conference Start Date: 3/6/18
Conference End Date: 3/8/18

Cost and Attendee Information
Total FDA cost of the conference: $47,348
Total number of individuals whose travel expenses were paid by the FDA: 32

Conference Justification Information
Explanation of how conference advanced the mission of FDA:
At the consortium, FDA Subject Matter experts participated in 21 separate workgroups to provide FDA vision and guidance to State awardee as they implement produce safety programs. This effort is designed to ensure funding is being used effectively and efficiently when developing individual State programs and to ensure awardees are on track.

General description of the scientific conference activities:
The Consortium provides an opportunity for 43 state awardees of PAR-16-137 to meet face-to-face with all produce stakeholders and work collaboratively on FDA-NASDA workgroup projects. FDA senior leadership provided guidance and direction to State awardees to ensure consistency of implementation on a national level.

66th Conference on Mass Spectrometry and Allied Topics

Conference Information
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: San Diego, California
Conference Start Date: 6/3/18
Conference End Date: 6/7/18

Cost and Attendee Information
Total FDA cost of the conference: $35,487
Total number of individuals whose travel expenses were paid by the FDA: 21

Conference Justification Information
Explanation of how conference advanced the mission of FDA:
It is critical that FDA staff remain current on the state of the art in this important analytical technique. Their interests include advancement of techniques and instrumentation in mass spectrometry, as well as fundamental research in chemistry, geology, forensics, biological sciences, and physics.

General description of the scientific conference activities:
The conference is attended by more than 6,500 scientists. Approximately 3,000 papers are presented as posters and talks The American Society for Mass Spectrometry membership includes over 8,500 scientists involved in research and development. Members come from academia, industry, and government laboratories.

The American Association for Clinical Chemistry 2018

Conference Information
Conference Title:
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Chicago, Illinois
Conference Start Date: 7/29/18
Conference End Date: 8/2/18

Cost and Attendee Information
Total FDA cost of the conference: $31,435
Total number of individuals whose travel expenses were paid by the FDA: 13

Conference Justification Information
Explanation of how conference advanced the mission of FDA:
Attendance at AACC provided FDA staff with an exceptional opportunity to hear vital research and learn about important new developments in laboratory medicine that meets FDA needs to stay ahead of changes in the field.

General description of the scientific conference activities:
The American Association for Clinical Chemistry (AACC) is a global scientific and medical professional organization dedicated to clinical laboratory science and its application to healthcare. As the leading event for laboratory medicine worldwide, the AACC Annual Scientific Meeting & Clinical Lab Expo is the place where breakthrough innovations in clinical testing and patient care are introduced to the healthcare world.